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Monday, October 27, 2014

Roche Seeks Fast-Track for Ebola Diagnostic Test

Roche Holding AG has filed its Ebola virus test for emergency use approval in the United States, in response to the world's worst outbreak of the disease, the drugmaker's head of diagnostics said on Thursday.

Roland Diggelman said Roche has an Ebola test that can run on its polymerase chain reaction (PCR) systems, but said it was currently only labelled for use in research purposes.

"We are in discussions for emergency use application by the FDA (Food and Drug Administration)," Diggelman told an analyst call after the company's third-quarter results.

A spokesman for Roche said the company has also filed for so-called CE mark approval in the European Union. The CE mark is awarded to products that comply with European regulations.

He said it takes approximately two hours for the company's Ebola test to detect the virus. It is possible to run around 480 samples per day on a single Roche LightCycler 480 machine. Only laboratories that fulfil specific safety requirements would be able to handle Ebola samples.

A total of 4,493 people have died from the world's worst Ebola outbreak on record and the situation in Guinea, Liberia and Sierra Leone is deteriorating, the World Health Organization (WHO) said on Wednesday.

Public anxiety about the disease has grown in the United States after a second Texas healthcare worker became infected with the disease after treating Liberian national Thomas Duncan.

The WHO recommends testing for viral ribonucleic acid (RNA) or viral antigen in suspected or probable cases of Ebola.